🏥 治験ポータル

治験一覧

8,963 件中 40214040 件を表示

散発性筋萎縮性側索硬化症(ALS)に対するペランパネル

完了NCT03019419第2相

To investigate the safety and the efficacy of perampanel in patients with sporadic amyotrophic lateral sclerosis

対象疾患:
ALS

手術で完全に除去されたグレードII髄膜腫と新たに診断された患者の治療における観察または放射線療法

募集中NCT03180268第3相

This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.

対象疾患:
Grade 2 MeningiomaIntracranial Meningioma

重度大動脈弁狭窄症患者への移植を目的としたACURATE TF™経大腿動脈生体弁:CE承認コホート

完了NCT03003650該当なし

First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and performance of the device from three different cohorts

対象疾患:
Symptomatic Aortic Stenosis

進行期ホジキンリンパ腫と新規診断された小児患者を対象としたブレンツキシマブ・ベドチン+アドリアマイシン、ビンブラスチン、ダカルバジンの併用療法に関する研究

実施中(募集終了)NCT02979522第1/第2相

The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as confirm the recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric participants with advanced stage newly diagnosed classical CD30+ Hodgkin Lymphoma (HL).

対象疾患:
Hodgkin Disease

慢性めまいに対するアクセプタンス&コミットメントセラピーと前庭リハビリテーション

完了NCT03029949該当なし

The purpose of this study is to examine the effectiveness of group acceptance and commitment therapy with vestibular rehabilitation for chronic dizziness, in comparison with self-treatment vestibular rehabilitation in addition to clinical management.

対象疾患:
Chronic Dizziness

進行がんまたは転移がんを有する日本人参加者を対象としたメレスチニブ(LY2801653)の研究

完了NCT03027284第1相

The main purpose of this study is to evaluate tolerability of merestinib monotherapy or in combination with other anti-cancer agents in Japanese participants with advanced and/or metastatic cancer.

対象疾患:
Advanced CancerBiliary Tract CarcinomaCholangiocarcinomaGall Bladder CarcinomaMetastatic Cancer2

iASSISTニーシステム搭載のPersona TKAとiASSISTニーシステム

完了NCT03227692該当なし

The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.

対象疾患:
Osteoarthritis, Knee

副甲状腺癌または原発性副甲状腺機能亢進症患者における高カルシウム血症治療のためのKHK7580の第3相試験

完了NCT03280264第3相

To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.

対象疾患:
Parathyroid CarcinomaPrimary Hyperparathyroidism

子宮頸がんの成人患者におけるセミプリマブの研究

完了NCT03257267第3相

The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: * To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy * To compare objective response rate (ORR) (partial response \[PR\] + complete response \[CR\]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy * To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) * To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

対象疾患:
Recurrent or Metastatic, Platinum-refractory Cervical CancerSquamous Cell Carcinoma (SCC)

進行B細胞悪性腫瘍を有する日本人成人患者を対象としたアカラブルチニブの第1相試験

実施中(募集終了)NCT03198650第1相

This is a multicenter, open-label Phase 1 study of acalabrutinib, a selective and irreversible Bruton's tyrosine kinase inhibitor, in Japanese adult patients with advanced B-cell malignancies. This study is divided into 3 parts: Part 1 (dose-confirmation phase), Part 2 (dose-expansion phase) and Part 3 (dose-confirmation phase for combination therapy).

対象疾患:
Part1: Advanced B-cell MalignanciesPart2: r/rCLL and r/rMCLPart3: Untreated CLL

再発または難治性多発性骨髄腫の日本人患者を対象としたJNJ-54767414(ダラツムマブ)の皮下投与に関する研究

完了NCT03242889第1相

The purpose of this study is to evaluate the tolerability and safety of subcutaneous (SC) delivery of co-formulated daratumumab and rHuPH20 preparation (DARA SC) in Japanese participants with relapsed or refractory multiple myeloma (MM).

対象疾患:
Multiple Myeloma

進行性前立腺がんの男性におけるレルゴリクスの安全性と有効性を評価する研究

完了NCT03085095第3相

The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (\< 50 nanograms/deciliter \[ng/dL\]) in participants with androgen-sensitive advanced prostate cancer.

対象疾患:
Prostate Cancer

日本人成人男性を対象としたE3112の単回静脈内投与試験

完了NCT03014895早期第1相

The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled, single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous dose of E3112.

対象疾患:
Healthy Male Volunteers

2型糖尿病患者におけるトレラグリプチンのQOL評価に関する研究

完了NCT03014479第4相

The purpose of this study is to assess the reduction in treatment burden during 12 weeks of trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy only.

対象疾患:
Type 2 Diabetes

この研究は、様々な種類のがん(固形がん)の患者を対象に、ホルモン療法の有無にかかわらず、アベマシクリブと併用したゼンツズマブの安全な投与量を見つけることを目的としています。また、肺がんおよび乳がんの患者におけるこれらの薬剤の有効性も検証します。

完了NCT03099174第1相

This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: * Xentuzumab in combination with abemaciclib * Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in participants with lung and breast cancer. Participants can stay in the study as long as they benefit from and can tolerate treatment. All participants get xentuzumab infusions and abemaciclib tablets. Participants who have breast cancer get different types of hormonal therapies in addition to xentuzumab and abemaciclib. For all participants, the size of the tumour is measured regularly. Doctors also regularly check the general health of the participants."

対象疾患:
Breast NeoplasmsNeoplasms

転移性去勢抵抗性前立腺がんの男性患者を対象とした、オラパリブ(リンパルザ™)とエンザルタミドまたはアビラテロン酢酸エステルとの比較試験(PROfound試験)

完了NCT02987543第3相

The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.

対象疾患:
Metastatic Castration-resistant Prostate Cancer

進行性悪性腫瘍患者におけるLHC165単剤療法およびPDR001との併用療法の安全性と有効性に関する研究

中止NCT03301896第1相

The purpose of this trial was to explore the clinical utility of two investigational agents in patients with advanced cancer. This was a multi-center, open-label Phase I/Ib study. The primary objectives of the trial were: * To characterize the safety and tolerability of intratumoral LHC165 in patients with solid tumors as a single agent and in combination with PDR001 * To determine and evaluate the maximum tolerated dose (MTD)/recommended dose (RD) for LHC165 as a single agent and in combination with PDR001

対象疾患:
Solid Tumors

IDH1変異を有する未治療の急性骨髄性白血病患者を対象とした、アザシチジンとの併用におけるAG-120(イボシデニブ)とプラセボの比較試験

実施中(募集終了)NCT03173248第3相

Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.

対象疾患:
AML Arising From Myelodysplastic Syndrome (MDS)Leukemia, Myeloid, AcuteNewly Diagnosed Acute Myeloid Leukemia (AML)Untreated AML

日本人2型糖尿病患者における、経口セマグルチドとデュラグルチドを1種類の経口血糖降下薬(OAD)と併用した場合の安全性および有効性の比較

完了NCT03015220第3相

This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic drug) in Japanese subjects with type 2 diabetes.

対象疾患:
DiabetesDiabetes Mellitus, Type 2

冠動脈CTと光干渉断層撮影における形態計測の比較

完了NCT03021382

The objective of this study is to evaluate the precision of semi-automated lumen boundary identification from coronary computed tomography angiography (cCTA) by current version of HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical coherence tomography (OCT) as reference standard.

対象疾患:
Coronary Artery Disease